In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
|Articles|June 1, 2010
- Applied Clinical Trials-06-01-2010
- Volume 0
- Issue 0
Applied Clinical Trials Digital Edition - June 2010
GLOBAL TRIALS : New Survey Baselines Global Sites Keys to Success in China Budgeting for Global Trials European Ethics Committees CRO/SPONSOR : Think About the Drug Label First LABS : 3-Prong Model for CV Safety Immune Response Screens a Necessity eCLINICAL : ePRO?s Tipping Point Also in this issue : FDA?s New Risk Approach to Site Inspections, EMA Speaks to Stem Cell Research, Mother Lode of Latent Research Data
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Biosimilars Make Headwayover 16 years ago
Business and News Update June 2010over 16 years ago
Electronic Integration Costsover 16 years ago
Strategic Immunogenicity Testingover 16 years ago
ePRO vs. Paperover 16 years ago
Today's Global Site Landscapeover 16 years ago
Changing Medicines, Changing Rulesover 16 years ago
Ethics Diversity Persistsover 16 years ago
Mastering Currency Fluctuationover 16 years ago
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Hierarchical composite endpoints analyzed through pairwise comparisons more accurately reflect multifaceted treatment benefit than time-to-first-event composites, but transparent outcome prioritization, patient involvement in ranking, and reporting of Net Treatment Benefit remain underutilized despite their importance to interpretation.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, offers practical guidance for clinical operations teams beginning their AI journey—making the case that the tools are more accessible than many assume and that waiting to start is a competitive risk in itself.
In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
The new effort combines adaptive platform trial design, AI-enabled site activation, nationwide data infrastructure, and patient data contribution tools to reduce timelines, costs, and patient burden across clinical development.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.
In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.
AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.
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